A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel Group Study to Evaluate the Efficacy and Safety of 50 mg/day of DVS SR in Adult Outpatients With Major Depressive Disor...

Update Il y a 4 ans
Reference: EUCTR2008-005424-85

A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel Group Study to Evaluate the Efficacy and Safety of 50 mg/day of DVS SR in Adult Outpatients With Major Depressive Disorder

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Extract

The primary objective is to compare the long-term efficacy and safety of treatment with DVS SR 50 mg/day versus placebo in MDD subjects stabilized on DVS SR, using a randomized withdrawal design. This comparison will be based on time to relapse between DVS SR and placebo treatment groups.


Inclusion criteria

  • The desvenlafaxine succinate sustained release formulation, DVS SR, is being used in development programs for the treatment of major depressive disorder (MDD)